NDC | 40046-0077-1 |
Set ID | aa5af5a5-6a21-4b60-99b0-1eaea361898c |
Category | HUMAN OTC DRUG LABEL |
Packager | MAKEUP ART COSMETICS |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two hours
- use a water resistant sunscreen if swimming or sweating
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
-
inactive ingredients
water\aqua\eau, dimethicone, butylene glycol, propanediol, glyceryl stearate, phenyl trimethicone, behenyl alcohol, trioctyldodecyl citrate, polymethylsilsesquioxane, ascorbyl glucoside, peg-40 stearate, polyglyceryl-10 pentastearate, octyldodecyl stearoyl stearate, tocopheryl acetate, tocopheryl linoleate/oleate, sodium hyaluronate, lecithin, squalane, cucumis sativus (cucumber) fruit extract, gentiana lutea (gentian) root extract, glycyrrhiza glabra (licorice) root extract, hordeum vulgare (barley) extract\extrait d'orge, hydrolyzed rice bran extract, laminaria saccharina extract, pyrus malus (apple) fruit extract, salicornia herbacea extract, scutellaria baicalensis root extract, triticum vulgare (wheat) germ extract, caffeine, glycerin, ergothioneine, octyldodecyl neopentanoate, polyglyceryl-6 polyricinoleate, cholesterol, sodium pca, oryzanol, trehalose, acetyl hexapeptide-8, bisabolol, dimethoxytolyl propylresorcinol, aluminum hydroxide, silica, urea, polyquaternium-51, sucrose, xanthan gum, ammonium acryloyldimethyltaurate/vp copolymer, sodium ethyltaurate/vp copolymer, sodium stearoyl lactylate, glycyrrhetinic acid, linoleic acid, stearic acid, isopropyl titanium triisostearate, disodium edta, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tetrahexyldecyl ascorbate, sodium dehydroacetate, phenoxyethanol, chlorphenesin [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499), zinc oxide (ci 77947)] <iln44257>
- Other information
- PRINCIPAL DISPLAY PANEL - 40 ML Bottle Carton
-
INGREDIENTS AND APPEARANCE
MAC LIGHTFUL CPLUS CORAL GRASS TINTED WITH RADIANCE BOOSTER BROAD SPECTRUM SPF030
octinoxate, octisalate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0077 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 81.75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 43.6 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 27.25 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 11.99 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPANEDIOL (UNII: 5965N8W85T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DOCOSANOL (UNII: 9G1OE216XY) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) PEG-40 STEARATE (UNII: ECU18C66Q7) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SQUALANE (UNII: GW89575KF9) CUCUMBER (UNII: YY7C30VXJT) GENTIANA LUTEA ROOT (UNII: S72O3284MS) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) APPLE (UNII: B423VGH5S9) SALICORNIA EUROPAEA (UNII: 6ADL50JAKW) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) WHEAT GERM (UNII: YR3G369F5A) CAFFEINE (UNII: 3G6A5W338E) GLYCERIN (UNII: PDC6A3C0OX) ERGOTHIONEINE (UNII: BDZ3DQM98W) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CHOLESTEROL (UNII: 97C5T2UQ7J) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GAMMA ORYZANOL (UNII: SST9XCL51M) TREHALOSE (UNII: B8WCK70T7I) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) LEVOMENOL (UNII: 24WE03BX2T) DIMETHOXYTOLYL PROPYLRESORCINOL (UNII: 4OD5GIH1UK) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) UREA (UNII: 8W8T17847W) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) ENOXOLONE (UNII: P540XA09DR) LINOLEIC ACID (UNII: 9KJL21T0QJ) STEARIC ACID (UNII: 4ELV7Z65AP) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0077-1 1 in 1 CARTON 11/01/2017 1 40 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2017 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(40046-0077) , REPACK(40046-0077) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(40046-0077) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(40046-0077) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0077) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0077) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(40046-0077) , REPACK(40046-0077) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 959338336 MANUFACTURE(40046-0077) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(40046-0077) , REPACK(40046-0077) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0077) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(40046-0077)